- High expression of FAP, the target of radionuclide therapeutic
development candidate FAP-2286, was observed across multiple tumor
types and correlated with FAP-2286 binding
- Clovis Oncology’s clinical development of FAP-2286 is underway
with the Phase 1/2 LuMIERE clinical trial now enrolling patients
with FAP-positive solid tumors
Clovis Oncology, Inc. (NASDAQ: CLVS) announced that nonclinical
data describing the expression of fibroblast activating protein
(FAP) in a variety of solid tumor types will be presented during
the AACR-NCI-EORTC Virtual International Conference on Molecular
Targets and Cancer Therapeutics, taking place October 7-10, 2021.
The analysis, conducted with its partner 3B Pharmaceuticals GmbH,
measured FAP expression in multiple tumor types using
immunohistochemistry (IHC) as well as the correlation between FAP
expression by IHC and in vitro binding of FAP-2286, Clovis’
peptide-targeted radionuclide therapy (PTRT) clinical development
candidate that targets FAP.
“We believe these findings across multiple solid tumor types
demonstrate the importance of FAP as a cancer target and underscore
the potential for 177Lu-FAP-2286 to treat patients with
FAP-expressing tumors,” said Dr. Thomas Harding, Executive Vice
President and Chief Scientific Officer of Clovis Oncology. “These
provide additional validation for our ongoing Phase 1/2 LuMIERE
clinical trial of FAP-2286, the first peptide-targeted radionuclide
therapeutic in clinical development targeting FAP, and support
investigation of FAP-2286 in a broad number of cancer indications.
This is representative of our commitment to emerge as a leader in
targeted radionuclide therapy by developing innovative
radiotherapies such as FAP-2286 for patients with hard-to-treat
cancers.”
To determine FAP protein expression in different tumor types, a
pan-tumor IHC screen was performed that included 360 samples
representing 16 different tumor types. For this analysis, high FAP
expression was defined as an overall H-score ≥30 in more than 30%
of the samples analyzed in a given tumor type. The IHC screen
showed high FAP expression in nine of the 16 solid tumor types
evaluated, including pancreatic ductal adenocarcinoma, cancer of
unknown primary, salivary gland, mesothelioma, colon, bladder,
sarcoma, squamous non–small cell lung, and squamous head and neck
cancers. High FAP expression was detected in both primary and
metastatic tumor samples and was independent of tumor stage or
grade.
The analysis also demonstrated that in most tumor types, FAP
expression was predominantly localized to the stroma surrounding
the tumor cells within the tumor microenvironment. FAP expression
in tumor cells was also observed: in cancers of mesenchymal origin,
such as sarcoma and mesothelioma, tumor-cell expression was common,
consistent, and strong; in cancers of epithelial origin, tumor-cell
FAP expression was rare and, when present, appeared weaker than in
the adjacent stroma.
A significant correlation was seen between FAP expression
observed by IHC and in vitro FAP-2286 binding as determined by
autoradiography, suggesting that FAP is an attractive target for
PTRT in a wide array of tumor types.
Following are details of the Clovis-sponsored presentation:
Poster Number: LBA032 - Pan-Cancer
Analysis of Fibroblast Activation Protein Alpha (FAP) Expression to
Guide Tumor Selection for the Peptide-Targeted Radionuclide Therapy
FAP-2286
Lead author: Tanya T. Kwan, PhD
Category: Radiotherapeutics
Date/Time: Thursday, October 7 at 9:00
am ET
The presentation and accompanying poster can also be viewed at:
https://clovisoncology.com/pipeline/scientific-presentations/
For more information about FAP-2286, Targeted Radionuclide
Therapy (TRT), or Clovis’ TRT development program CLICK HERE.
About FAP-2286
FAP-2286 is a clinical candidate under investigation as a
peptide-targeted radionuclide therapy (PTRT) and imaging agent
targeting fibroblast activation protein (FAP). FAP-2286 consists of
two functional elements; a targeting peptide that binds to FAP and
a site that can be used to attach radioactive isotopes for imaging
and therapeutic use. High FAP expression has been shown in
pancreatic ductal adenocarcinoma, cancer of unknown primary,
salivary gland, mesothelioma, colon, bladder, sarcoma, squamous
non–small cell lung, and squamous head and neck cancers. High FAP
expression was detected in both primary and metastatic tumor
samples and was independent of tumor stage or grade. Clovis holds
US and global rights for FAP-2286 excluding Europe, Russia, Turkey,
and Israel.
FAP-2286 is an unlicensed medical product.
About Targeted Radionuclide Therapy
Targeted radionuclide therapy is an emerging class of cancer
therapeutics, which seeks to deliver radiation directly to the
tumor while minimizing delivery of radiation to normal tissue.
Targeted radionuclides are created by linking radioactive isotopes,
also known as radionuclides, to targeting molecules (e.g.,
peptides, antibodies, small molecules) that can bind specifically
to tumor cells or other cells in the tumor environment. Based on
the radioactive isotope selected, the resulting agent can be used
to image and/or treat certain types of cancer. Agents that can be
adapted for both therapeutic and imaging use are known as
“theranostics.” Clovis, together with licensing partner 3B
Pharmaceuticals, is developing a pipeline of novel, targeted
radiotherapies for cancer treatment and imaging, including its lead
candidate, FAP-2286, an investigational peptide-targeted
radionuclide therapeutic (PTRT) and imaging agent, as well as three
additional discovery-stage compounds.
About the LuMIERE Clinical Study
LuMIERE is a Phase 1/2 study evaluating FAP-2286 as a
peptide-targeted radionuclide therapy (PTRT) targeting fibroblast
activation protein, or FAP, in patients with advanced solid tumors
(NCT04939610). The Phase 1 portion of the LuMIERE study is
evaluating the safety of the investigational therapeutic agent and
will identify the recommended Phase 2 dose and schedule of
lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled
with gallium-68 (68Ga-FAP-2286) will be utilized as an
investigational imaging agent to identify patients with
FAP-positive tumors appropriate for treatment with the therapeutic
agent. Once the Phase 2 dose is determined, Phase 2 expansion
cohorts are planned in multiple tumor types.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing, and commercializing innovative anti-cancer
agents in the US, Europe, and additional international markets.
Clovis Oncology targets development programs at specific subsets of
cancer populations, and simultaneously develops, with partners, for
those indications that require them, diagnostic tools intended to
direct a compound in development to the population that is most
likely to benefit from its use. Clovis Oncology is headquartered in
Boulder, Colorado, with additional office locations in the US and
Europe. Please visit www.clovisoncology.com for more
information.
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Clovis Oncology,
they are forward-looking statements reflecting the current beliefs
and expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Examples of forward-looking statements contained in this press
release include, among others, statements of our intentions and
expectations for our development and discovery programs, including
the timing and pace of pre-clinical development, plans for clinical
development, plans for additional applications of the FAP-2286
peptide, including potential indications, tumor types and
combination trials, and regulatory plans with respect to FAP-2286.
Such forward-looking statements involve substantial risks and
uncertainties that could cause Clovis Oncology’s actual results,
performance or achievements to differ significantly from those
expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, the uncertainties inherent
in drug discovery and pre-clinical and clinical development,
including the outcome of pre-clinical studies and clinical trials,
whether initial results, findings or research will support future
studies or development, whether future study results will be
consistent with previous study findings or other results, including
pre-clinical studies, results in named-patient or similar programs
or clinical trials, whether additional studies not originally
contemplated are determined to be necessary, the timing of
initiation, enrollment and completion of planned studies and
actions by the FDA, the EMA or other regulatory authorities
regarding data required to support drug applications and whether to
approve drug applications. Clovis Oncology undertakes no obligation
to update or revise any forward-looking statements. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to the business of the
company in general, see Clovis Oncology’s Annual Report on Form
10-K, Quarterly Reports on Form 10-Q and its other reports filed
with the Securities and Exchange Commission.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211007005030/en/
Clovis Investor Contacts: Anna Sussman, 303.625.5022
asussman@clovisoncology.com or Breanna Burkart, 303.625.5023
bburkart@clovisoncology.com
Clovis Media Contacts: US Lisa Guiterman,
301.347.7964 clovismedia@clovisoncology.com
Europe Jake Davis, +44 (0) 203.946.3538
Jake.Davis@publicisresolute.com
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